Standard
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AS ISO 5649:2025
[Current]Medical laboratories - Concepts and specifications for the design, development, implementation and use of laboratory-developed tests
AS ISO 5649:2025 identically adopts ISO 5649:2024, which specifies requirements for assuring quality, safety, performance and documentation of laboratory-developed tests (LDTs) as per their intended use for the diagnosis, prognosis, monitoring, prevention or treatment of medical conditions
Published: 11/04/2025
Pages: 34
Table of contents
Cited references
Content history
Table of contents
Header
About this publication
Preface
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
4.1 Rationale for laboratory-developed tests (LDTs)
4.2 Feasibility assessment
4.3 Management system
4.3.1 General
4.3.2 Transfer of laboratory-developed tests (LDTs)
4.3.3 Control of subcontractors
5 Requirements for the design and development of laboratory-developed tests (LDTs)
5.1 Determination of LDT performance specifications
5.1.1 General
5.1.2 Intended use
5.1.3 Scientific validity
5.1.4 Scientific literature
5.2 Risk management
5.2.1 Risk management system
5.2.2 Risk differentiation for the LDT
5.3 Essential principles for safety and performance
5.4 Preliminary and pilot testing
6 Requirements for the performance evaluation of laboratory-developed tests (LDTs)
6.1 Performance evaluation
6.2 Validation master plan
6.3 Analytical performance
6.3.1 General
6.3.2 Measurement uncertainty (MU)
6.4 Clinical performance
6.5 Excluded performance characteristics
6.6 Software verification and validation
6.7 Validation documentation and final acceptance criteria
6.8 Post validation activities of verification
7 Implementation, monitoring and retirement of laboratory-developed tests (LDTs)
7.1 Transfer into routine use
7.2 Result reporting and interpretation
7.3 Maintenance
7.4 Monitoring and review activities
7.5 Change management
7.6 Retirement of laboratory-developed tests (LDTs)
Annex A
Bibliography
Cited references in this standard
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